Home NDC 63783-401 ORTHO GUARD
Product NDC 63783-401
11-digit product format 637830401
Labeler code 63783
Product ID 63783-401_2a1d770f-d9a7-4980-a1f2-cf4df96d0f40
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route ORAL
Labeler Massco Dental A Division of Dunagin Pharmaceuticals
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-01-01
Substance SODIUM FLUORIDE
Active strength 4.4 mg/10mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ORTHO GUARD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 4.4 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63783-401-16 ORTHO GUARD 473 mL in 1 BOTTLE GEL, DENTIFRICE 473 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63783-401 ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 1 package rows 20231218_8d3e0dd0-b584-413b-adf3-5c2d05ab72dd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 42 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05a9cee1-bd6e-6b93-e063-6294a90a5c10 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Advanced Whitening Prebiotic Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f546470a-7fae-4988-e053-2995a90ab61b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Whitening Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de97dbea-dc8c-ebfa-e053-2995a90a2270 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b1020b-a1c3-e1eb-e063-6394a90ac266 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Complete Protection Prebiotic Mint Blast SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f547a468-d2fd-7176-e053-2995a90a5539 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. b4530d56-3a17-6868-e053-2995a90a2524 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Total Care Strong Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de996aeb-9ac0-836f-e053-2a95a90aeda6 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05aafc53-49ca-eacd-e063-6394a90a606b 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b18bb6-9fbf-469b-e063-6294a90a4f2f 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 9c820740-9148-3a9c-e053-2a95a90a3968 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials Fresh Aloe Green Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. a3b21ceb-5aa5-29b4-e053-2a95a90a9545 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE LG H&H Co., Ltd. 05b25897-460c-2dfb-e063-6294a90ada3b 2025-01-01 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H Co., Ltd. 05b1f105-6f75-7a45-e063-6394a90a58bc 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE LG H&H Co., Ltd. 05b25083-12f3-7a85-e063-6394a90a492e 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE LG H&H Co., Ltd. 05b276a1-3778-104d-e063-6294a90a7537 2025-01-01 Warnings Exact identifier application number: M021 kids kare STANNOUS FLUORIDE DEN-MAT HOLDINGS, LLC. 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91 2024-12-31 Warnings Exact identifier application number: M021 Kids Kare SODIUM FLUORIDE DEN-MAT HOLDINGS, LLC. 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca 2024-12-31 Warnings Exact identifier application number: M021 Morning Fresh SODIUM FLUORIDE Dynarex Corporation 1d0457d7-0228-4ea3-9755-73bacd2201e6 2024-12-27 Warnings Exact identifier application number: M021 Bubble Fresh Toothpaste, with Fluoride BUBBLE FRESH TOOTHPASTE, WITH FLUORIDE Dynarex Corporation 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6 2024-12-26 Warnings Exact identifier application number: M021 Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios, Inc. b3006c29-1f7f-4d9f-ab46-5a36df1a0471 2024-12-25 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63783-401-16 63783040116 473 mL in 1 BOTTLE (63783-401-16) 473 ml 1989-01-01 0000-00-00 No No Current